- Data Consistent Across All Patient Subgroups, Including Demographic Subgroups, by Baseline Androstenedione Levels and by Baseline Glucocorticoid Dose

- 数据在所有患者亚组中一致，包括人口统计学亚组、基线雄烯二酮水平和基线糖皮质激素剂量。

- Findings to be Presented at the 2025 Joint Congress of the European Society for Paediatric Endocrinology and the European Society of Endocrinology

- 研究结果将在2025年欧洲儿科内分泌学会与欧洲内分泌学会联合大会上发表

SAN DIEGO

圣地亚哥

,

，

May 8, 2025

2025年5月8日

/PRNewswire/ --

/PRNewswire/ --

Neurocrine Biosciences, Inc.

神经生物科学公司

(Nasdaq:

（纳斯达克：

NBIX

NBIX

) today announced new results from subgroup analyses of the Phase 3 CAHtalyst™ Pediatric study. The analyses showed that, consistently across all of the different subgroups analyzed, pediatric patients with classic congenital adrenal hyperplasia maintained or improved their androstenedione levels with .

）今天宣布了来自CAHtalyst™儿科三期研究的亚组分析的新结果。分析显示，在所有不同亚组中，经典先天性肾上腺增生的儿科患者均维持或改善了他们的雄烯二酮水平。

CRENESSITY™ (crinecerfont)

CRENESSITY™（crinecerfont）

while reducing glucocorticoid dosing. These data will be presented at the 2025 Joint Congress of European Society for Paediatric Endocrinology and the European Society of Endocrinology in

同时减少糖皮质激素的剂量。这些数据将在2025年欧洲儿科内分泌学会和欧洲内分泌学会联合大会上展示。

Copenhagen, Denmark

丹麦，哥本哈根

.

。

Overproduction of androstenedione, a key adrenal androgen, in pediatric patients with congenital adrenal hyperplasia (CAH) can lead to abnormal growth and development, premature puberty and various developmental challenges. For decades, high levels of androstenedione (A4) were treated with glucocorticoids (GCs) only..

先天性肾上腺增生（CAH）的儿科患者中，关键的肾上腺雄激素——雄烯二酮的过量生产，可能导致生长和发育异常、性早熟以及各种发育挑战。数十年来，高水平的雄烯二酮（A4）仅通过糖皮质激素（GCs）进行治疗。

'High-dose steroids are often accompanied by side effects and complications,' said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. 'By enabling patients to maintain or improve their androgen levels while reducing their reliance on high-dose glucocorticoids, CRENESSITY has the potential to meaningfully enhance long-term outcomes, helping patients with both the hormonal imbalances that characterize CAH, as well as the challenges associated with chronic high-dose glucocorticoid treatment.'.

“高剂量类固醇常常伴随着副作用和并发症，”Neurocrine Biosciences首席医疗官Eiry W. Roberts博士说道，“通过使患者在减少对高剂量糖皮质激素依赖的同时维持或改善其雄激素水平，CRENESSITY有潜力显著提升长期疗效，帮助患者应对导致CAH的激素失衡问题，以及与慢性高剂量糖皮质激素治疗相关的挑战。”

The CAHtalyst Pediatric study included 103 patients who were randomly assigned to receive either CRENESSITY (N=69) or a placebo (N=34) for 28 weeks. The primary endpoint was the least-squares (LS) mean change from baseline in A4 levels (before the morning GC dose) at Week 4. A key secondary endpoint was GC dose reduction at Week 28.

CAHtalyst儿科研究纳入了103名患者，他们被随机分配接受CRENESSITY（N=69）或安慰剂（N=34），持续28周。主要终点是第4周时A4水平（早晨GC剂量前）与基线相比的最小二乘（LS）均值变化。一个关键的次要终点是第28周时GC剂量的减少。

Prespecified subgroup analyses of the primary endpoint and post-hoc subgroup analyses of GC dose reduction at Week 28 were conducted for region, sex, race, age, body mass index, pubertal stage and baseline A4 levels; and weight and baseline GC dose subgroups were also analyzed for GC dose reduction at Week 28.

预先设定的亚组分析针对主要终点，以及事后亚组分析针对第28周GC剂量减少的情况，按地区、性别、种族、年龄、体重指数、青春期阶段和基线A4水平进行；还对体重和基线GC剂量亚组进行了第28周GC剂量减少的分析。

This comprehensive approach allowed for a thorough evaluation of treatment effects across diverse patient characteristics..

这种方法允许对不同患者特征的治疗效果进行全面评估。

Across all subgroups, CRENESSITY enabled reduction of GC doses while maintaining or improving A4 levels:

在所有亚组中，CRENESSITY 在减少 GC 剂量的同时维持或改善了 A4 水平：

Substantial Reduction in Adrenal Androgens at Week 4:

第4周肾上腺雄激素显著减少：

CRENESSITY significantly reduced A4 levels from baseline compared with placebo (overall, -6.9 versus +2.5 nmol/L; LS mean difference [LSMD]: -9.3 nmol/L;

与安慰剂相比，CRENESSITY显著降低了A4水平（总体上，-6.9对比+2.5 nmol/L；最小二乘均值差[LSMD]：-9.3 nmol/L；

p

p

=0.0002); subgroup analyses of A4 reduction at Week 4 were consistent with the results in the overall population.

=0.0002)；第4周A4减少的亚组分析与总体人群的结果一致。

Substantial Reduction in GC Doses at Week 28:

第28周GC剂量显著减少：

GC doses were significantly reduced from baseline with CRENESSITY (while maintaining or improving A4 levels) compared with placebo (overall, -18.0% versus +5.6%; LSMD: -23.5%;

与安慰剂相比，使用CRENESSITY后，GC剂量从基线显著减少（同时保持或改善A4水平）（总体上，-18.0% 对 +5.6%；LSMD：-23.5%；）。

p

p

<0.0001); subgroup analyses of GC reduction at Week 28 were consistent with the results in the overall population.

<0.0001）；第28周的GC减少亚组分析与总体人群的结果一致。

CRENESSITY was generally well tolerated in the CAHtalyst Pediatric study. The most common adverse reactions (≥4% for CRENESSITY and greater than placebo) were headache, abdominal pain, fatigue, nasal congestion and nosebleed.

CRENESSITY 在 CAHtalyst 儿科研究中通常耐受性良好。最常见的不良反应（CRENESSITY ≥4% 且高于安慰剂）包括头痛、腹痛、疲劳、鼻塞和流鼻血。

The ability to reduce GC doses while simultaneously maintaining or improving androgen levels represents a significant advancement in CAH management. These results suggest that CRENESSITY may improve long-term outcomes in patients across various subgroups.

在减少GC剂量的同时维持或提高雄激素水平的能力代表了CAH管理的一项重大进步。这些结果表明，CRENESSITY可能改善不同亚组患者的长期预后。

Additional presentations at the 2025 Joint Congress of the European Society for Paediatric Endocrinology and the European Society of Endocrinology include:

在2025年欧洲儿科内分泌学会和欧洲内分泌学会联合大会上的其他报告包括：

Crinecerfont Improves Reproductive Hormones in Classic Congenital Adrenal Hyperplasia: 1-Year Results from the Phase 3 CAHtalyst™ Adult Study (Presentation RC13.5)

Crinecerfont 改善经典先天性肾上腺皮质增生症的生殖激素：来自 3 期 CAHtalyst™ 成人研究的 1 年结果（报告 RC13.5）

A Double-blind Study of Modified-release Hydrocortisones, Chronocort versus Plenadren, in Adrenal Insufficiency (CHAMPAIN) (Presentation OC13.6)

肾上腺功能不全中改良释氢化可的松的双盲研究，Chronocort与Plenadren的比较（CHAMPAIN）（演讲OC13.6）

About Congenital Adrenal Hyperplasia

关于先天性肾上腺增生症

Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens, which are essential for life. Approximately 95% of CAH cases are caused by variants of the CYP21A2 gene that leads to deficiency of the enzyme 21-hydroxylase.

先天性肾上腺增生症 (CAH) 是一种罕见的遗传病，由酶缺乏引起，导致肾上腺类固醇激素（如皮质醇、醛固酮和肾上腺雄激素）生成异常，而这些激素对生命至关重要。大约 95% 的 CAH 病例是由 CYP21A2 基因变异引起的，该变异导致 21-羟化酶缺乏。

Severe deficiency of this enzyme leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens.

这种酶的严重缺乏会导致肾上腺无法产生足够的皮质醇，并且在大约75%的情况下，也无法产生醛固酮。由于患有先天性肾上腺增生症（CAH）的个体仍然能够产生雄激素，那些通常用于制造皮质醇但未被使用的前体物质反而会导致过量雄激素的产生。

If left untreated, CAH can result in salt wasting, dehydration and even death..

如果不及时治疗，CAH会导致盐分流失、脱水甚至死亡。

Historically, exogenous glucocorticoids (GCs) have been used to correct the endogenous cortisol deficiency, but doses higher than those for cortisol replacement (supraphysiologic) are needed to lower the elevated levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at high doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis.

历史上，外源性糖皮质激素 (GCs) 一直被用于纠正内源性皮质醇缺乏症，但需要比皮质醇替代剂量更高（超生理剂量）才能降低促肾上腺皮质激素 (ACTH) 和肾上腺雄激素的升高水平。然而，高剂量的 GC 治疗会带来类固醇过量相关的严重且显著的并发症，包括代谢问题如体重增加和糖尿病、心血管疾病以及骨质疏松症。

Additionally, long-term treatment with high-dose GCs may have psychological and cognitive impacts, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, in addition to fertility issues in both sexes.

此外，长期使用大剂量GCs可能会对心理和认知产生影响，如情绪和记忆的变化。肾上腺雄激素过多在儿科患者中与骨骼生长和发育异常有关，女性健康问题包括面部毛发过度生长和月经不规律，同时还会导致两性生育问题。

The symptoms of high ACTH may include testicular adrenal rest tumors (TARTs) or ovarian adrenal rest tumors (OARTs)..

ACTH过高的症状可能包括睾丸肾上腺残留肿瘤（TARTs）或卵巢肾上腺残留肿瘤（OARTs）。

About The CAHtalyst™ Pediatric Study

关于CAHtalyst™儿科研究

The Phase 3 CAHtalyst global

第3阶段CAHtalyst全球

registrational

注册的

studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY in children and adults with classic congenital adrenal

这些研究旨在评估CRENESSITY在患有经典先天性肾上腺增生的儿童和成人中的安全性、有效性和耐受性。

hyperplasia

增生

(

(

CAH

先天性肾上腺增生症

) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever

) 由于21-羟化酶缺乏症。CAHtalyst研究是有史以来规模最大的

interventional

介入的

clinical trial program in classic

经典临床试验项目

CAH

先天性肾上腺增生症

, including 285 pediatric and adult patients.

，其中包括285名儿科和成人患者。

The

The

CAHtalyst Pediatric study

CAHtalyst儿童研究

included 103 pediatric patients four to 17 years of age. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment could enable customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved..

纳入了103名4至17岁的儿科患者。该研究测试了两个问题。第一个问题评估了四周的CRENESSITY治疗是否可以改善雄激素控制。第二个问题评估了额外24周的CRENESSITY治疗是否能够在维持或改善雄烯二酮水平的同时实现个性化的糖皮质激素（GC）减量。

Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in

CAHtalyst III期研究的数据支持了CRENESSITY获得美国食品和药物管理局的批准。

December 2024

2024年12月

. The open-label extension treatment portions of both studies are ongoing.

两项研究的开放标签扩展治疗部分正在进行中。

About CRENESSITY™ (crinecerfont)

关于CRENESSITY™（crinecerfont）

CRENESSITY is a potent and selective oral

CRENESSITY 是一种强效且选择性的口服药物

corticotropin-releasing

促肾上腺皮质激素释放

factor type 1 receptor (CRF

因子类型1受体 (CRF)

1

1

) antagonist developed to reduce and control excess

) 拮抗剂开发用于减少和控制过剩

adrenocorticotropic

促肾上腺皮质激素的

hormone (

激素 (

ACTH

促肾上腺皮质激素

) and adrenal androgens through a

）以及通过一种

non-glucocorticoid

非糖皮质激素

(

(

GC

垃圾回收机制

) mechanism for the treatment of classic congenital adrenal

) 机制用于治疗经典的先天性肾上腺

hyperplasia

增生

(

(

CAH

先天性肾上腺增生症

). Antagonism of CRF

). CRF的拮抗作用

1

1

receptors in the pituitary has been shown to decrease

垂体中的受体已被证明会减少。

ACTH

促肾上腺皮质激素

levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with

水平，从而减少肾上腺雄激素的产生，并可能减轻相关症状

CAH

先天性肾上腺增生症

. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of

强大的临床研究数据表明，使用CRENESSITY降低肾上腺雄激素水平可以实现更低、更符合生理需求的剂量。

GCs

垃圾收集器

to replace missing

替换缺失

cortisol

皮质醇

.

。

CRENESSITY comes in capsules and an oral solution. The capsule formulation is available in 50 mg and 100 mg doses. The oral solution is available as a 50 mg/mL strength formulation. For adults 18 years of age and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal.

CRENESSITY有胶囊和口服溶液两种形式。胶囊剂型有50毫克和100毫克两种剂量。口服溶液的剂型为50毫克/毫升。对于18岁及以上的成人，推荐剂量为每次100毫克，每日两次，随餐口服。对于四至17岁且体重低于55公斤（121磅）的儿科患者，推荐剂量根据体重计算，每日两次，随餐口服。

For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement..

对于体重超过55公斤（121磅）的儿科患者，推荐剂量为每次100毫克，每日两次，随餐口服。医疗保健提供者可以根据患者的需求，协助确定合适的制剂使用方案。接受CRENESSITY治疗的患者应继续进行糖皮质激素（GC）疗法以补充皮质醇。

Important Information

重要信息

Approved Uses

批准的用途

CRENESSITY (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH).

CRENESSITY（克里内塞隆）是一种处方药，与糖皮质激素（类固醇）联合使用，用于控制4岁及以上患有经典先天性肾上腺增生症（CAH）的成人和儿童的雄激素（类似睾酮的激素）水平。

IMPORTANT SAFETY INFORMATION

重要安全信息

Do not take CRENESSITY if you:

如果您：请勿服用CRENESSITY

Are allergic to crinecerfont, or any of the ingredients in CRENESSITY.

对克里内塞方或CRENESSITY中的任何成分过敏。

CRENESSITY may cause serious side effects, including:

CRENESSITY 可能引起严重的副作用，包括：

Allergic Reactions.

过敏反应。

Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY.

过敏反应的症状包括喉咙发紧、呼吸或吞咽困难、嘴唇、舌头或脸部肿胀以及皮疹。如果您对CRENESSITY产生过敏反应，请立即寻求紧急医疗帮助，并停止服用CRENESSITY。

Risk of Sudden Adrenal Insufficiency or Adrenal Crisis With Too Little Glucocorticoid (Steroid) Medicine.

糖皮质激素（类固醇）药物过少可能导致突发性肾上腺功能不全或肾上腺危象的风险。

Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis.

先天性肾上腺增生症患者如果未摄入足够的糖皮质激素（类固醇）药物，可能会发生急性肾上腺功能不全或肾上腺危象。在使用CRENESSITY治疗期间，您应继续服用糖皮质激素（类固醇）药物。某些情况，如感染、严重损伤或休克，可能会增加急性肾上腺功能不全或肾上腺危象的风险。

Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine..

告诉您的医疗保健提供者，如果在治疗期间您受到严重伤害、感染、疾病或有计划的手术。您的医疗保健提供者可能需要更改您服用的糖皮质激素（类固醇）药物的剂量。

Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you

在服用CRENESSITY之前，请告诉您的医疗保健提供者您的所有健康状况，包括如果您

are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

怀孕或计划怀孕，或正在哺乳或计划哺乳。

Tell your healthcare provider about all the medicines you take,

告诉您的医疗保健提供者您所服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements.

包括处方药和非处方药、维生素以及草本补充剂。

The most common side effects of CRENESSITY in adults include

CRENESSITY 在成人中最常见的副作用包括

tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain.

疲倦、头痛、头晕、关节痛、背痛、食欲下降和肌肉疼痛。

The most common side effects of CRENESSITY in children include

CRENESSITY在儿童中最常见的副作用包括

headache, stomach pain, tiredness, nasal congestion, and nosebleeds.

头痛、腹痛、疲倦、鼻塞和流鼻血。

These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at

这些并非 CRENESSITY 的所有可能副作用。如需了解有关副作用的医疗建议，请咨询您的医疗保健提供者。我们鼓励您向 FDA 报告处方药的负面副作用。访问 MedWatch 网站

www.fda.gov/medwatch

www.fda.gov/medwatch

or call 1-800-FDA-1088.

或拨打 1-800-FDA-1088。

Dosage Forms and Strengths:

剂型和规格：

CRENESSITY is available in 50 mg and 100 mg capsules, and as an oral solution of 50 mg/mL.

CRENESSITY 有 50 毫克和 100 毫克的胶囊剂型，以及 50 毫克/毫升的口服溶液。

Please see full

请查看完整内容

Prescribing Information

处方信息

.

。

About Neurocrine Biosciences, Inc.

关于Neurocrine Biosciences公司

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.

Neurocrine Biosciences是一家领先的神经科学-focused生物制药公司，拥有一个简单的使命：减轻高需求患者的痛苦。我们致力于为神经、神经内分泌和神经精神疾病治疗不足的患者发现和开发改变生活的疗法。

The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

公司多样化的产品组合包括FDA批准的治疗药物，用于迟发性运动障碍、亨廷顿病相关的舞蹈症、典型的先天性肾上腺增生、子宫内膜异位症*和子宫肌瘤*，同时在我们核心治疗领域中还有多个化合物处于中期至后期临床开发阶段的强大研发管线。

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit .

三十年来，我们运用对神经科学以及大脑和身体系统之间相互联系的独特见解来治疗复杂疾病。我们不懈追求药物研发，以减轻衰弱性疾病和病症带来的负担，因为您值得拥有勇敢的科学。欲了解更多信息，请访问 。

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The NEUROCRINE BIOSCIENCES Logo, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. CRENESSITY and CAHtalyst are trademarks of Neurocrine Biosciences, Inc.

神经内分泌生物科学标志、NEUROCRINE和“你值得勇敢的科学”是Neurocrine Biosciences公司的注册商标。CRENESSITY和CAHtalyst是Neurocrine Biosciences公司的商标。

Forward-Looking Statements

前瞻性声明

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH); the value and benefits CRENESSITY brings to patients with CAH; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results.

除历史事实外，本新闻稿还包含涉及若干风险和不确定性的前瞻性陈述。这些陈述包括但不限于以下方面的陈述：CRENESSITY 在治疗经典先天性肾上腺增生症 (CAH) 方面可能带来的益处；CRENESSITY 为 CAH 患者带来的价值和益处；Neurocrine Biosciences 确保患者获得 CRENESSITY 的能力；以及我们对 CRENESSITY 进行的临床试验结果是否能够反映真实世界的结果。

Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY, including the extent to which patients and physicians accept and adopt CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights.

可能导致实际结果与前瞻性陈述中所述或暗示的结果存在重大差异的因素包括但不限于以下：与Neurocrine Biosciences的业务和财务相关的风险和不确定性，以及与CRENESSITY商业化相关的风险和不确定性，包括患者和医生接受和采用CRENESSITY的程度；CRENESSITY是否从第三方支付方获得足够的补偿；与竞争产品和技术变革相关的风险和不确定性，这些可能限制对CRENESSITY的需求；公司依赖第三方进行与CRENESSITY相关的开发和制造活动所带来的风险，以及公司管理这些第三方的能力；CRENESSITY的额外监管提交可能不会发生或无法及时提交的风险；FDA或其他监管机构可能对CRENESSITY做出不利决定的风险；CRENESSITY在批准后的承诺或要求可能被延迟的风险；以及CRENESSITY可能因专有或监管权利而被排除在商业化之外的风险。

March 31, 2025

2025年3月31日

. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law.

Neurocrine Biosciences 免责声明：除非法律要求，否则不承担在本新闻发布日期之后更新其中包含的声明的义务。

© 2025 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-CFT-US-0021   05/2025

© 2025 Neurocrine Biosciences, Inc. 保留所有权利。CAP-CFT-US-0021   05/2025

SOURCE Neurocrine Biosciences, Inc.

来源：Neurocrine Biosciences, Inc.

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